Dynasty Trial Shell 62mm Group G, REF 3300-GG62, Rx only, Non-Sterile, 1 each, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002 Orthopaedic instrument used for the preparation of the implant site prior to device implantation.
This recall has been terminated (originally issued September 17, 2008).
- Company
- Wright Medical Technology Inc
- Recall Initiated
- May 20, 2008
- Posted
- September 17, 2008
- Terminated
- January 25, 2009
- Recall Number
- Z-2215-2008
- Quantity
- 128 units
- Firm Location
- Arlington, TN
- Official Source
- View on FDA website ↗
Reason for Recall
Trials are 2.5mm larger than marked.
Distribution
Worldwide Distribution --- including USA and Canada.
Lot / Code Info
Lot Nos.: 037386983 and 117456822
Root Cause
Component change control
Action Taken
The firm initiated their recall on May 20, 2008 by issuing a Field Notice to their distributors and followed with telephone calls on May 21 and 22, 2008 requesting the return of the products. The firm then issued letters to their distributors on June 4, 2008 explaining the problem and requesting return of the product from their inventory and from their consignees. The letter included a "fax back" response page to ensure the receipt of the notice. The hospitals were notified of the recall also on June 4, 2008 by means of letters, delivered via Fed Ex, addressed to Hospital Administrators, Risk Managers, and Orthopaedic Department Managers.